10 results
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19ms
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Sources: EU EUDAMED, US FDA
SERO-STAT STAPHYLOCOCCUS TEST
FDA 510(k)
FDA Class 1
·Microbiology
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41428110980·Titanium TLIF Spacer, 28 x 11 x 9mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40428110980·PEEK TLIF Spacer, 28 x 11 x 9mm, 8 deg
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
FDA 510(k)
FDA Class 2
·Radiology
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
PULSE-GENERATOR, PACEMAKER, EXTERNAL
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code DTE·October 31, 2012
CAN AM RELION 1/2CC INS SYR 31X5/16
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·August 12, 2010
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021